510(k) · Cleared
ClearedOsteonics Long Arm Containment Ring
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteonics Corp. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on May 20, 1998 after a 28-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- May 20, 1998
- Review
- 28 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981452 | Osteonics Long Arm Containment Ring | Osteonics Corp. | 1998 | — |
| +1 | K990158 | Osteonics Combination Screw Ring/Blocker | Osteonics Corp. | 1999 | — |
| +2 | K020293 | Osteonics Spinal System | Howmedica Osteonics Corp. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KWP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Osteonics® Spinal System Low Profile Cap Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990158 | Osteonics Combination Screw Ring/Blocker | 1999 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K990158 (Osteonics Corp., 1999) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The uses for the Osteonics® Long Arm Containment Ring, as part of the legally marketed Osteonics® Spinal System, are as follows: Non-Pedicular Use; fixation of the T4-S2 spine: . Long and short curve scoliosis . Vetebral fracture or dislocation . Spondylolisthesis . Degenérative disc disease (defined as back pain of discogeric origin with degeneration of the disc confirmed by history and radiographic studies). . Previously faiied fusion . Spinal tumor…
Read the full statement (150 words)
The uses for the Osteonics® Long Arm Containment Ring, as part of the legally marketed Osteonics® Spinal System, are as follows:
Non-Pedicular Use; fixation of the T4-S2 spine:
. Long and short curve scoliosis
. Vetebral fracture or dislocation
. Spondylolisthesis
. Degenérative disc disease (defined as back pain of discogeric origin with degeneration of the disc confirmed by history and radiographic studies).
. Previously faiied fusion
. Spinal tumor
Pedicular Use:
. When used as a pedicle screw system, the system is intended for patients: (a) having severe spendylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. Pedicle screws are not intended for placement in pedicles above L3.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981452 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981452: Osteonics Long Arm Containment Ring.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981452
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026